RANDOMIZED STUDY OF EFFECT OF IBOPAMINE ON SURVIVAL IN PATIENTS WITH ADVANCED SEVERE HEART-FAILURE

Background Drugs that improve symptoms in patients with heart failure must also be assessed for their effects on survival. Ibopamine stimula tes DA-1 and DA-2 receptors and causes peripheral and renal vasodilata tion; the drug improves symptoms of heart failure. We assessed the eff ect of ibopamine on survival in patients with advanced heart failure i n a multicentre, randomised placebo-controlled study. Methods Patients with advanced severe heart failure (New York Heart Association classe s III and IV) and evidence of severe left-ventricular disease, who wer e already receiving optimum treatment for heart failure, were randomly allocated oral ibopamine 100 mg three times daily or placebo. The pri mary endpoint was all-cause mortality. The study was designed to recru it 2200 patients, and the minimum duration of treatment would be 6 mon ths. We did intention-to-treat and on-treatment analyses; a post-hoc s ubgroup analysis was also done. Findings After we had recruited 1906 p atients the trial was stopped early, because of an excess of deaths am ong patients in the ibopamine group. 232 (25%) of 953 patients in the ibopamine group died, compared with 193 (20%) of 953 patients in the p lacebo group (relative risk 1.26 [95% CI 1.04-1.53], p=0.017). The ave rage length of follow-up was 347 days in the ibopamine group and 363 d ays in the placebo group. In multivariate analysis, only the use of an tiarrhythmic drugs at baseline was a significant independent predictor of increased fatality in ibopamine-treated patients. Interpretation I bopamine seems to increase the risk of death among patients with advan ced heart failure who are already receiving optimum therapy, but the r easons for this increase are not clear. Our finding that antiarrhythmi c treatment was a significant predictor of increased mortality in ibop amine-treated patients may be important, but exploratory analyses must be interpreted with caution.